NCT05891886

Brief Summary

A study of how supplemental oxygen helps patients with acute pulmonary embolism (PE). Hypothesis: Oxygen affects right ventricular dysfunction (RVD) in patients with acute pulmonary embolism (PE) primarily by relieving hypoxic pulmonary vasoconstriction and reducing pulmonary pressure (PA) pressure, and that this process is metabolically driven.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for early_phase_1

Timeline
14mo left

Started Oct 2023

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Oct 2023Jun 2027

First Submitted

Initial submission to the registry

May 4, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

3.7 years

First QC Date

May 4, 2023

Last Update Submit

June 12, 2025

Conditions

Pulmonary EmbolismVenous ThromboembolismMetabolomicsOxygen Inhalation Therapy

Keywords

Pulmonary EmbolismPERight ventricular dysfunction

Outcome Measures

Primary Outcomes (4)

  • Pulmonary artery systolic pressure (PASP)

    PASP is measured on bedside echocardiogram

    30 minutes after study treatment (supplemental oxygen) or placebo (room air)

  • Pulmonary artery systolic pressure (PASP)

    PASP is measured on bedside echocardiogram

    60 minutes after study treatment (supplemental oxygen) or placebo (room air)

  • Pulmonary artery systolic pressure (PASP)

    PASP is measured on bedside echocardiogram

    90 minutes after study treatment (supplemental oxygen) or placebo (room air)

  • Pulmonary artery systolic pressure (PASP)

    PASP is measured on bedside echocardiogram

    180 minutes after study treatment (supplemental oxygen) or placebo (room air)

Secondary Outcomes (8)

  • Right ventricular to left ventricular ratio (RV/LV)

    30 minutes after study treatment (supplemental oxygen) or placebo (room air)

  • Right ventricular to left ventricular ratio (RV/LV)

    60 minutes after study treatment (supplemental oxygen) or placebo (room air)

  • Right ventricular to left ventricular ratio (RV/LV)

    90 minutes after study treatment (supplemental oxygen) or placebo (room air)

  • Right ventricular to left ventricular ratio (RV/LV)

    180 minutes after study treatment (supplemental oxygen) or placebo (room air)

  • Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays

    30 minutes after study treatment (supplemental oxygen) or placebo (room air)

  • +3 more secondary outcomes

Study Arms (2)

Supplemental oxygen delivered by facemask

EXPERIMENTAL

Patients with acute PE will be randomized to breathing supplemental oxygen by non-rebreather face mask first. Subjects will alternate treatments (supplemental oxygen or room air) every 30 minutes for 90 minutes (e.g. T=30, T=60, T=90) and then will maintain their treatment (oxygen or room air) for a total of 180 minutes.

Drug: Oxygen TherapyDevice: Non-rebreather mask

Room air delivered by facemask

ACTIVE COMPARATOR

Patients with acute PE will be randomized to breathing room air by non-rebreather face mask first. Subjects will alternate treatments (supplemental oxygen or room air) every 30 minutes for 90 minutes (e.g. T=30, T=60, T=90) and then will maintain their treatment (oxygen or room air) for a total of 180 minutes.

Device: Non-rebreather mask

Interventions

Oxygen TherapyDRUG

Study subjects will be asked to breathe supplemental, or extra, oxygen during several time periods.

Supplemental oxygen delivered by facemask
Non-rebreather maskDEVICE

Non-rebreather mask is a non-invasive oxygen supplementation device that is used to provide continuous oxygen flow, typically in a hospital setting.

Also known as: NRM (Non-rebreather mask)
Room air delivered by facemaskSupplemental oxygen delivered by facemask

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ≥18 years old
  • Confirmed Pulmonary Embolism (PE) on imaging \<24 hours prior to enrollment
  • New symptom onset and / or worsening symptoms \<72 hours
  • Confirmation of right ventricular dysfunction (RVD) by clinician
  • Oxygen saturation ≥90% while breathing room air

You may not qualify if:

  • Hemodynamic instability
  • Use of vasopressors or mechanical circulatory support
  • Planned use of thrombolytics or plan for embolectomy
  • Oxygen saturation \<90% while breathing room air
  • New onset arrhythmia
  • History of pulmonary hypertension, severe chronic obstructive pulmonary disease (COPD) requiring home oxygen or chronic steroid use, hypoventilation syndrome requiring continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP), or congestive heart failure (CHF) with LV ejection fraction \< 40% or chronic oxygen therapy
  • Known pregnancy
  • Vasodilator medication used in the past 24 hours
  • Symptom onset ≥72 hours
  • Inability to wear a face mask
  • Inability to obtain adequate baseline echocardiogram

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (1)

  • Lyhne MD, Liteplo AS, Zeleznik OA, Dudzinski DM, Andersen A, Shokoohi H, Al Jalbout N, Eke OF, Morone CC, Huang CK, Heyne TF, Kalra MK, Kabrhel C. Supplemental oxygen for pulmonary embolism (SO-PE): study protocol for a mechanistic, randomised, blinded, cross-over study. BMJ Open. 2024 Nov 12;14(11):e091567. doi: 10.1136/bmjopen-2024-091567.

    PMID: 39532350DERIVED

MeSH Terms

Conditions

Pulmonary EmbolismVenous ThromboembolismVentricular Dysfunction, Right

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesThromboembolismVentricular DysfunctionHeart Diseases

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Christopher Kabrhel, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Kabrhel, MD, MPH

CONTACT

617-726-7622ckabhrel@mgb.org

Blair Alden Parry, CCRC, BA

CONTACT

617-724-4758bparry@mgh.harvard.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patient
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Emergency Medicine; Attending Physician

Study Record Dates

First Submitted

May 4, 2023

First Posted

June 7, 2023

Study Start

October 1, 2023

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

June 15, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data (IPD) available to other researchers. The results of this study will be published in scientific journals and presented at national/international scientific meetings.

Locations

US(1)